REDOY RANJAN Department of Cardiac Surgery ...

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“Experience is the name everyone gives to their mistakes!” (Oscar Wilde). Thanks to human heart! By which- we live! (Cecil Rhodes). “The bloods around men's ...
REDOY RANJAN MBBS, MRCS ED, MRCS ENGLAND MS (Cardiovascular & Thoracic Surgery)

Department of Cardiac Surgery Bangabandhu Sheikh Mujib Medical University Shahbag-1000, Dhaka, Bangladesh.

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REDOY RANJAN

“PREGNANCY FOLLOWING OPEN HEART SURGERY”

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Dedicated ToMy dear Wife-Nita!

Some hearts are so broken, even you can’t fix ’em! (Daniel James Waters) 3

ACKNOWLEDGEMENT

I owe my heartfelt gratitude and indebtedness to my Professor Dr. Md. Aftab Uddin, Department of cardiac surgery, Bangabandhu Sheikh Mujib Medical University (BSMMU), for his patience guidance. I am also grateful to Professor Dr. Asit Baran Adhikary, Chairman, Department of cardiac surgery, BSMMU for his active help, guidance and valuable suggestions. I shall ever remain indebted to the authority of national heart foundation hospital & research institute and national institute of cardiovascular diseases and hospital.

Don’t be afraid to do a new procedure; be prepared! (Daniel James Waters) 4

Disclosure of interestsNo potential conflict of interest with respect to the research, authorship, or publication of this article.

Surgeons must be very careful When they take the knife! Underneath their fine incisions Stirs the Culprit—LIFE! (Emily Dickson)

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PREFACE Pregnancy following open heart surgery having greater risk of adverse effect like bleeding, fetal loss and congenital malformation especially with oral anticoagulants that must be weighed against the risk of intracardiac thrombosis. Therefore, health status of pregnant women with a history of open heart surgery should be evaluated at a regular interval of time throughout the period of pregnancy and also after delivery. Proper antenatal follow up and management in a woman with history of open heart surgery improves maternal and fetal outcome and there is no contraindication for pregnancy to the patients with good NYHA functional class.

REDOY RANJAN MBBS, MRCS ED, MRCS (England) MS (Cardiovascular & Thoracic Surgery) Cardiovascular and Thoracic Surgeon Bangabandhu Sheikh Mujib Medical University Shahbag-1000, Dhaka, Bangladesh.

July 2017.

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PREGNANCY OUTCOME FOLLOWING OPEN HEART SURGERY

ABSTRACT Background: Pregnancy having greater risk of bleeding, fetal loss and congenital malformation especially with oral anticoagulants therapy that must be weighed against the risk of intracardiac thrombosis. Methods: This retrospective cohort study was undertaken between 2014 and 2016. Total 56 pregnancies were evaluated. Patients were divided into two groups: group I (n = 37) includes pregnancy with history of intracardiac repair except valvular heart disease, while group II (n = 19) includes pregnancy with prosthetic valve received anticoagulation therapy. Result: In this study, mean age was 24.7±3.8 years and 25.1±3.8 years respectively, in group I and group II. In total 44 pregnancies (78.57%) ended in healthy live births (91.89% patients in group I and 52.63% patients in group II); 11 pregnancies (19.64%) terminated in abortion (8.1% patients in group I and 42.1% patients in group II). One (5.3%) baby was born with congenital malformation in group II. Warfarin 7

embryopathy was detected in one (5.3%) case. Mean birth weight was found 2.8±0.6 kg in group I and 2.5±0.3 kg in group II. The mean APGAR score was found 8.5±0.7 in group I and 8.1±0.7 in group II. Twenty-five (25%)

percent

complications.

of

our

Eleven

study (19.64%)

population patients

developed developed

maternal cardiac

complications during pregnancy. Seven (12.5%) patients developed heart failure (4 patients in group I and 3 patients in group II) and prosthetic valve thrombosis was in three patients (15.79%) in group II. One of our patients (1.78%) has had residual ASD. Majority of the patients was found good health status (89.2% patients in group- I and 63.2% patients in group- II) during and after pregnancy. Conclusion: Proper antenatal care and early risk stratification are the fundamental measures to improve the maternal and fetal outcome in a patient of open heart surgery.

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INTRODUCTION The primary cause of non-obstetric mortality in pregnancy is cardiac disease. Although the coincidence of cardiovascular diseases and pregnancy decreased over the last decades, the incidence of heart disease occurrence are estimated to 1- 4% of pregnancies and mitral valvular disease is the responsible pathology in most of these cases 1. Though post-operative prognosis after open heart surgery is improved, women still afraid of having babies after open heart surgery. Only a small number of women with a history of open heart surgery get pregnant, though professional experience in this field shows that if properly managed, outcomes of pregnancies after open heart surgery is encouraging. However, there is no doubt these women require vigilant care for their mental and physical wellbeing during pregnancies for having positive outcomes. Physiological changes during pregnancy include a gradual increase in cardiac output, in blood volume, in heart rate and myocardial oxygen consumption, all of which may cause decompensation in women with underlying cardiac disease. The functional deterioration that results from the physiological circulatory overload observed in the gestational period 9

in patients with a reduced functional reserve is frequently refractory to medical therapy. Cardiac surgery has provided a favorable maternal prognosis in these cases2. The hemodynamic changes of pregnancy put extra circulatory burden on the heart, which aggravates during labour and immediately following delivery3. Additionally, it is also reported that women treated for congenital heart diseases, such as isolated septal defects, tetralogy of Fallot or cardiac manifestations of Marfan’s syndrome, have more number of safe pregnancies4. Women who underwent valve replacement with mechanical prostheses have a lower risk of worsening cardiac functions due to additional burden of pregnancy compared to that of biological (tissue valves) prostheses4. During pregnancy, platelet number and activation of coagulation cascades are increased, in contrast fibrinolytic activity is decreased. These changes increase the risk of valvular thrombotic complications in patients with previous mitral valve replacement which may necessitate emergent surgical re-intervention with high maternal and fetal mortality5. The management of a pregnant woman with a prosthetic heart valve requires important considerations, especially when it comes to 10

maintaining anticoagulation. Warfarin is considered to be a safe and effective anticoagulant for patients with prosthetic heart valves. However, treatment during pregnancy poses many difficulties, not least during the first trimester, due to its ability to cross the placenta and its associated fetotoxicity. Treatment with heparin during the first trimester decreases the rate of embryopathy, but increases maternal morbidity and mortality6. The risk of thromboembolism, miscarriage, and premature birth is felt to be higher in patients who have prosthetic heart valves requiring anticoagulation5. If open heart surgery is required, it is best undertaken in the second trimester7. However, this procedure is associated with high obstetric and fetal risks, with emphasis on the impact of extracorporeal circulation (ECC) and anesthetic agents. Thus, surgical treatment of heart diseases during pregnancy and puerperium is performed only in selected cases. Reported common complications during pregnancies with a history of heart surgery are: cardiac arrhythmias, hypercoagulability, risk of thromboembolism, thrombosis of prostheses, abortion, premature delivery or intrauterine fetal death or intrauterine growth retardation. 11

Thus, pregnancy in women with prosthetic mechanical heart valve replacement is problematic and troublesome even now. Interestingly, it has been suggested that most of the cardiac patients can tolerate the stress of normal vaginal delivery, so increasing rate of cesarean section do not imply better care8. Although concerns remain about the outcome of pregnancy in this high risk group of women and proper management during pregnancy can produce positive outcomes. There is no study on the effects of pregnancies on the maternal and fetal health during pregnancy and immediately after delivery following open heart surgery in our country. However, studies on other population shows that the functional status of the women during pregnancy is a better predictor of maternal and fetal outcome than that of the type of lesion requiring surgery9. So, study on pregnancy outcome following open heart surgery, can explore idea about the effects of surgery on pregnancy and management of a pregnant woman especially with anticoagulation therapy after cardiac valve replacement.

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RATIONALE OF THE STUDY Pregnancy with a history of open heart surgery are commonly complicated by cardiac arrhythmias, hypercoagulability, risk of thromboembolism, thrombosis of prostheses, abortion, premature delivery, teratogenicity, intrauterine fetal death. Therefore, health status of pregnant women with a history of open heart surgery should be evaluated at a regular interval throughout the period of pregnancy and immediately after delivery. There is no study about the effects of pregnancies on the maternal and fetal health during pregnancy and immediately after delivery following open heart surgery in this country. The aim of the present study was to evaluate maternal and fetal outcome in pregnant woman with history of open heart surgery in order to make the strategies for improving pregnancy outcomes in future.

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HYPOTHESIS Proper antenatal follow up and management in a woman with history of open heart surgery decrease maternal and fetal morbidity and mortality during pregnancy and immediately after delivery. OBJECTIVES: General Objective: 1. To describe occurrence of the maternal and fetal outcome during pregnancy and immediately after delivery in women with open heart surgery. Specific Objectives: 1. Assessment of mortality and major morbidities in a pregnant woman with history of open heart surgery. 2. Assessment of pregnancy and fetal abnormalities associated with anticoagulation therapy. 3. To evaluate the heart function during pregnancy and immediately after delivery in women with open heart surgery. 4. Identify the major risk factors during pregnancy among the patient of postoperative open heart surgical status. 14

SELECTION CRITERIA OF STUDY POPULATION Inclusion criteria: 1. Pregnant women (age ≤ 35 years) having history of open heart surgery for congenital heart disease and valvular heart disease. Exclusion criteria: 1. Pregnancy at elderly age (>35 years) with history of open heart surgery. 2. Systemic diseases such as end stage renal disease, hepatic failure, respiratory failure or any mental retardation. 3. Redo open heart surgeries. 4. NYHA classification: Class-3 or onwards

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MATERIALS AND METHODS This retrospective cohort study was undertaken between 2014 and 2016 in the Department of cardiac surgery, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh. Total 56 pregnancies were evaluated. Patients were divided into two groups: group I (n = 37) includes pregnant women with history of intra-cardiac repair for heart diseases except valvular heart disease, while group II (n = 19) includes pregnant women with valvular surgery received anticoagulation therapy throughout the pregnancy. Prior to commencement of this study, permission was taken from the concerned departmental academic and technical committee and also from the Institutional Review Board in order to undertake the study. All patients enrolled in this study were explained about the nature and purpose of the study and about the questionnaire used for this study. An informed written consent was taken from each of them. A standardized semi-structured data collection sheet was used to collect necessary information of the study subject.

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Pregnant woman with history of open heart surgery that fulfills the selection criteria was enrolled in the study. The details of cardiac lesion and surgery in all cases were recorded. The women were under joint care of obstetricians and cardiac surgeons. From the date of first reporting, a follow up was started. Evaluation of health status, especially heart function at first visit, then made their subsequent visit schedule according to necessity of each case. After first visit a follow up schedule was planned at 3rd month, 6th month, 9th month and according to necessity of each case during pregnancy. Echocardiography, ultrasound of pregnancy profile, serology and coagulation profile was performed at first visit and when indicated. At 18 – 20 week of gestation, an ultrasound examination was done for detection of fetal abnormalities. After 36 weeks of gestation, all women without any complications, was advised for hospitalization and spontaneous normal delivery was awaited unless there were any obstetric indications. In other cases, elective Cesarean section was done. After birth, babies were examining by pediatricians. The weight, APGAR score, signs of any congenital anomalies and detailed examination were done and recorded in the notes.

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Patients taking anticoagulants should continue their treatment according to their prescription throughout their pregnancies. Administration of heparin in first trimester (Dose: 5000IU subcutaneously 12 hourly), thereafter warfarin till 2 weeks before EDD (expected date of delivery) according to standard dose adjusted by monitoring of INR, depending on type and position of cardiac valve and then heparin again till after delivery. Coagulation profile was monitored by measuring activated partial thromboplastin time (aPTT) for heparin and prothrombin time (PT) and international normalized ratio (INR) for warfarin at frequent interval and the doses of drugs was adjusted accordingly. Anticoagulants were stopped before delivery and resumed 6 to 12 hours following delivery. Other medications, such as digoxin, beta blockers or diuretics were

adjusted

accordingly.

Post-operative cardiac

arrhythmias,

hypercoagulability, thromboembolism, thrombosis of prostheses, LV dysfunction, abortion, threatened abortion, per vaginal bleeding, premature delivery, teratogenic effect or intrauterine fetal death, angina, MI, TIA, Stroke, death and others variable was recorded. All data was collected during follow up by interviewing the patient.

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Categorical variables were presented in the form of frequency and percentage and quantitative data was presented in the form of mean and standard deviation. The results were presented in tables. Chi-Square test was used to analyse the categorical variables, shown with cross tabulation. Student t-test or Unpaired t-test was used for continuous variables to test statistical difference. P values ≤0.05 was considered as statistically significant.

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RESULTS This study included 56 pregnant women with history of open heart surgery. The baseline characteristics of study population are given in the Table- I. The population was divided into two groups. In group I, there was 37 (Thirty-seven) pregnant women with history of open heart surgery for heart diseases other than valvular heart diseases. Group II consisted of 19 (Nineteen) pregnant women with history of valve replacement or valve reconstructive surgery where anti-coagulant or anti-platelet drug was used. Demographic variables of study population Table I shows demographic variable of the study population, it was observed that 75.7% patients were belonged to age 21-30 years in group I and 16 (84.2%) in group II. The mean age was found 24.7±3.8 years in group I and 25.1±3.8 years in group II. Majority (56.8%) patients were housewives in group I and 15 (78.9%) in group II. Almost half (45.9%) patients had completed HSC education in group I and 7 (36.8%) in group II. The differences were not statistically significant (p>0.05) between two groups in each variable.

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Table I: Distribution of the study patients according to demographic variable (n=56). Demographic variable

Group-I

Group-II

(n=37)

(n=19)

P value

N

%

n

%

≤20

6

16.2%

2

10.5%

21-30

28

75.7%

16

84.2%

>30

3

8.1%

1

5.3%

Mean±SD

24.7±3.8

25.1±3.8

Range (min, max)

18, 33

20, 33

Age (in years)

a0.711ns

Occupational status Student

11

29.7%

3

15.8%

House wife

21

56.8%

15

78.9%

Service holder

5

13.5%

1

5.3%

Primary

2

5.4%

0

0.0

S.S.C

3

8.1%

5

26.3%

H.S.C

17

45.9%

7

36.8%

Graduate

15

40.5%

7

36.8%

b0.255ns

Educational status

b0.238ns

ns= not significant; ap value reached from unpaired t-test, bp value reached from chi square test. 22

Types of open heart surgery in group- I Table II shows types of open heart surgery in group I. In group I, majority 31 (83.8%) patient was found ASD repair, 4 (10.8%) was VSD repair, 1 (2.7%) was TOF and 1 (2.7%) was Myxoma.

Table II: Distribution of the study patients on the basis of the type of open heart surgery in group I (n=37). Type of open heart surgery Number of patients Percentage ASD repair

31

83.8%

VSD repair

4

10.8%

TOF

1

2.7%

Myxoma

1

2.7%

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Types of open heart surgery in group- II Table III shows types of open heart surgery in group II. In group II, 13 (68.4%) patients had mechanical valve, 2 (10.5%) patients had tissue valve and 4 (21.1%) patients had valve reconstruction surgery. In group II, majority 15 (78.9%) patients received anti-coagulant and 9 (47.4%) patients received heparin in first trimester.

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Table III: Distribution of the study patients on the basis of information regarding open heart surgery in group II (n=19).

Open heart surgery

Number of patients Percentage

(Type of valve surgery) Mechanical valve replacement

13

68.4%

Tissue valve replacement

2

10.5%

Valve reconstruction

4

21.1%

Yes

15

78.9%

No

4

21.1%

Yes

9

47.4%

No

10

52.6%

Use of anti-coagulant

Use of heparin in first trimester

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NYHA classes during study period Table IV shows NYHA classes of the study patients. It was observed that majority (89.2%) patients was found NYHA 1-2 classes in group I and 16 (84.2%) in group II. The difference was not statistically significant (p>0.05) between two groups.

Table IV: Distribution of the study patients according to NYHA classes during study period (n=56). NYHA classes

1-2

Group-I

Group-II

(n=37)

(n=19)

N

%

n

%

33

89.2%

16

84.2%

P value

0.444ns 3-4

4

10.8%

3

15.8%

ns= not significant p value reached from chi square test.

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Maternal outcome of study population Table V shows maternal outcome of study population. In 1st trimester, three (8.1%) patients had spontaneous miscarriage in group I and 8 (42.1%) in group II. Four (10.8%) patients were found to have adverse haemodynamic events in group I and 3 (15.8%) in group II. In first trimester, spontaneous miscarriage was statistically significant (p